Required a RA Associate for a global pharma company!
Maintenance of post approval registration files intended for different global areas, including preparation and submission of change supplements and variations, annual reports, license renewals.
Support for initial R D submissions for different global areas, including registration file preparation and response to health authorities information requests depending on products and fields
Handling change controls to provide regulatory strategies, assessments and requirements.
Regulatory guidance.
Work with various interfaces in Israel and abroad including EU, US, Canada, in a complex work environment. Participation in meetings at the local and global level.
Participation in new work procedures development or improvement.
Work that requires creative thinking and tasks management skills, team work, multi-tasks management and high responsiveness.
Requirements: Education- B.Sc. or M.Sc. in Pharmacy/Life Sciences/Chemistry/Biology- must.
English at a very high level - speaking, reading and writing must.
Experience in registration in the field of pharmaceuticals or medical device OR experience in development of analytical methods for drug product must (High advantage to regulatory experience).
Familiarity with the various regulatory requirements must.
Experience in post-approval regulatory requirements and submissions for pharmaceuticals and in working with health authorities in particular EU countries, FDA- an advantage.
Familiarity with the regulatory requirements for sterile, biological and combination product - an advantage.
Writing and analyzing skills.
המשרה מיועדת לנשים ולגברים כאחד.